Pia

Att 4 PIA Form approved 10 Jun 2019.pdf

Formative Research and Tool Development

PIA

OMB: 0920-0840

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question
1

OPDIV:

2

PIA Unique Identifier:

2a Name:

Answer
CDC

Assessment of Gonorrhea Case Interviewing in STD Surveillance
General Support System (GSS)
Major Application

3

The subject of this PIA is which of the following?

Minor Application (stand-alone)
Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Implementation
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

No
Yes
No
Agency
Contractor
POC Title

Health Scientist

POC Name

Brandy Maddox

POC Organization NCHHSTP/DSTDP/PDQIB
POC Email

[email protected]

POC Phone

404.639.8511
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

Not applicable

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

Not applicable
The purpose of this qualitative information collection is to
assess the barriers and facilitators contributing to variations in
gonorrhea case (GC) interview completion rates among the 10
sexually transmitted disease (STD) Surveillance Network (SSuN)
Cycle III jurisdictions.

11 Describe the purpose of the system.

We will 1) document factors contributing to variations in GC
case interview completion rates across the SSuN sites, 2)
attempt to identify supportive factors that would facilitate
interview completion, and 3) use findings to address barriers
and implement strategies to improve completion of GC case
interviews and develop a plan of action to address key
recommendations.
Findings from the qualitative interviews will help increase STD
program capacity to help Centers for Disease Control (CDC)
Division of STD Prevention (DSTDP) identify programmatic
changes and provide guidance related to GC interviewing as
an SSuN activity and assist relevant SSuN site personnel in a
position to use the results to further strengthen their GC
interviewing practices.

CDC/DSTDP staff involved with this assessment will identify
eligible staff through SSuN site Principal Investigators (PIs) and
Describe the type of information the system will
by examining personnel lists. The team will request name, date
collect, maintain (store), or share. (Subsequent
of birth, phone numbers, and E-Mail address for all staff on the
12
questions will identify if this information is PII and ask list, and will use that list to recruit participants and invite them
about the specific data elements.)
to participate and to schedule the in-depth interview. This
contact information will be handwritten on paper, and not be
computerized on a form.
The planned study design will use purposive, targeted
sampling to recruit 50 persons. These 50 staff will be selected
from the 10 SSuN sites.

Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

Data will be collected from 50 semi-structured, 60-minute long,
in-person qualitative interviews. The in-depth interviews will
include open-ended questions designed to elicit information
on the factors related to GC case interview completion to help
document facilitators and barriers, and their perspectives on
the SSuN GC interviewing activity in their jurisdiction. Interview
questions will examine staff characteristics (i.e., training, job
background, responsibilities), attitudes and perceptions
towards interviewing, interview processes and procedures, and
community context (e.g., health department reputation, oversampling).
Although name, date of birth, phone number, and email
address data are collected, they will not be transmitted to CDC
nor will any record be retrievable by any element of PII. None
of the PII is linked to the study questions or study data.

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Yes

14 Does the system collect, maintain, use or share PII?

Indicate the type of PII that the system will collect or
15
maintain.

No
Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID

Other...

Other...

Other...

Other...

Other...

Employees
Public Citizens
16

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?
18 For what primary purpose is the PII used?
19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

<100
The primary purpose of PII is to identify and recruit appropriate
staff from the SSuN sites to participate in the assessment.
Not applicable

20 Describe the function of the SSN.

Not applicable

20a Cite the legal authority to use the SSN.

Not applicable

21

Identify legal authorities governing information use This request is authorized by Title III – General Powers and
Duties of the Public Health Service, Section 301 (241.)a.
and disclosure specific to the system and program.
Research and investigations generally.

22

Are records on the system retrieved by one or more
PII data elements?

Yes
No

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Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources
23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

24 Is the PII shared with other organizations?

0290-0840 (18AVE)
Yes
No
PIs will provide the initial gateway to approach staff for
participation. CDC/DSTDP staff involved with this assessment
will identify eligible staff through SSuN site PIs and by
examining personnel lists. The study team will request name
and contact information for all staff on the list, and will use that
list to recruit participants and invite them to participate and to
schedule the in-depth interview.

Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.

At the beginning of the in-depth interview, a member of the
DSTDP team will review the purpose of the assessment with
the participant and answer any questions they might have. The
participant will be asked to provide signed informed consent.
This includes permission to audio record the interview.
The consent process which is a discussion between the
participant and the study staff notifies individuals that their
name will not be recorded and anything said during the
interview will be confidential and will not be shared with other
staff or supervisors. Their name also will not be used when
discussing their responses with others. The information
provided will be stored securely and will only be available to
members of the study team.

26

Is the submission of PII by individuals voluntary or
mandatory?

Voluntary
Mandatory

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Participants may withdraw or revoke their participation at any
Describe the method for individuals to opt-out of the time. This will be done during the interview or by sending a
written notice to the DSTDP team. Recruitment contact
collection or use of their PII. If there is no option to
27
information is separate from the study data. If participants
object to the information collection, provide a
withdraw their permission, no new information will be
reason.
gathered and the participant will not participate in the
assessment.
Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.
Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

Individuals can be contacted via phone or email by the DSTDP
team to notify them of any major changes to the system.

Participants will be provided contact information and
instruction to contact either the PIs or CDC’s Human Research
Protection Office.
Participants' contact information to schedule the in-depth
interview will be handwritten on paper, and not be
computerized on a form. When not in active use, the papers
containing the contact information will be stored in locked
cabinets separate from other study data at the CDC/DSTDP
team office. These papers with the participant’s contact
information will be destroyed after the interview is completed
and the interview data have been fully transcribed and verified
for accuracy.
The DSTDP team will confirm the accuracy of the information
each time they contact a participant by phone, email, and/or
during study visits. If staff are unable to contact the participant
after multiple attempts, the participant will be withdrawn from
recruitment attempts.
Users

Users include the DSTDP team
involved in the assessment for

Administrators
31

Identify who will have access to the PII in the system
and the reason why they require access.

Developers
Contractors
Others

Describe the procedures in place to determine which
Roles and responsibilities to access PII will be limited to study
32 system users (administrators, developers,
investigators accessing recruitment and interview data.
contractors, etc.) may access PII.

Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

Access to PII will be restricted to Institutional Review Board
(IRB) individuals trained in human subject protections. All PII is
collected for a specific and identifiable purpose with access
restricted to specific job tasks and individuals who perform
those tasks. Access to PII in study data collected for the
purposes of analysis is limited to the study investigators.

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Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?
Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

CDC personnel are required to complete the annual Security
and Privacy Awareness Training to make them aware of their
responsibilities for protecting the information being collected
and maintained.
As part of the IRB approval process, interviewers submit proof
of completion of recent ethics training. This process involves
substantial content regarding privacy and confidentiality.
Interviewers also must commit to CDC that they will comply
with Health and Human Services Protection of Human Subjects
regulations 45 CFR part 46.
All CDC staff involved in the conduct of federally funded
human subjects research must complete select in-depth
scientific and ethics trainings, including sections on privacy
and confidentiality, via the Collaborative Institutional Training
Initiative (CITI) based on the type of research on which study
staff are engaged as required by the IRB for engaging human
subjects research.
Yes
No
CDC uses the CDC Records Control Schedule for determining
retention and destruction of PII, specifically, section 04-4-40
Surveillance Report of STD Activity, which prescribes that
records be retained and destroyed when no longer needed for
administrative or research purposes or when 30 years old,
whichever comes first.

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Technical
Access to the server is controlled using individual access
controls and only authorized users will have access to the data.
Administrative
The CDC study team has defined that roles and responsibilities
to access PII is limited to only study investigators who will have
access to recruitment and interview data.
Physical
CDC data will be stored on a secured server at a facility
protected by guards. Additional protections include Personal
Identification Verification (PIV) card access protections. Guards
are also located inside buildings to control ingress and egress.
Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Participants will be invited to provide their contact information
in order to schedule the in-depth interview. This contact
information will be handwritten on paper, and not be
computerized on a form. When not in active use, the papers
containing the contact information will be stored in locked
cabinets separate from other study data at the CDC/DSTDP
team office. These papers with the participant’s contact
information will be destroyed after the interview is completed
and the interview data have been fully transcribed and verified
for accuracy.
All interview audio files will be stored on the recorders;
interview notes (not full transcripts) will be done in house by
DSTDP team members by listening to the recording device and
supplementing handwritten notes to stand-alone computers
that are not networked, taking care to remove any PII that may
have been transcribed accidentally. No final interview
transcript or other computerized data file will contain any PII
from the participant.

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes

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Reviewer Questions
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Answer
Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Reviewer
Notes
10

Is the PII appropriately limited for use internally and with third parties?

Yes
No

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

Reviewer
Notes
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

General Comments

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OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2019.06.12
19:12:44 -04'00'

HHS Senior
Agency Official
for Privacy

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